The purpose of this study is to evaluate the safety and performance of an experimental device called the LuX-Valve Plus System in people who have severe leaks or regurgitation around the tricuspid valve of their heart and who are at high risk for surgical treatment. The tricuspid valve is the valve on the right side of the heart that controls blood flow from the upper and lower right chambers of the heart. The LuX-Valve Plus is designed to replace the patient’s diseased natural tricuspid valve and consists of a tri-leaflet valve (3 moving tissue parts made from cow heart tissue), delivery system to deliver the implant to the diseased tricuspid valve position, introducer kit used to facilitate the insertion of delivery system, and stabilizer to support the whole delivery system. Participants will undergo the tricuspid valve replacement procedure and clinic visits.
What is the full name of this clinical trial?
TRIal to Evaluate TraNsvenous TrIcuspid Valve ReplacemenT with Lux Valve Plus System in Patients with Severe or Greater Tricuspid Regurgitation - Safety and Clinical Performance PROTOCOL NO: JSNL-CIP-TVS02-01FDA